ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Adv Cardio Sys Dbl Lumen Balloon Dilata Catheter.

Pre-market Notification Details

Device IDK844972
510k NumberK844972
Device Name:ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View,  CA  04043
ContactJane E Beggs
CorrespondentJane E Beggs
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View,  CA  04043
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-24
Decision Date1985-05-16

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